Catheter Lubricant: Sterile Lubricant, FDA Class and Types

This page describes products and general use; it is not medical advice.

A catheter lubricant is a lubricant, commonly supplied as a sterile water-soluble jelly, used to ease the entry of a catheter into a body orifice. In US regulation, FDA treats it as a patient lubricant, a Class I device under 21 CFR 880.6375. Clinic staff, supply buyers and students use this page to see what the product is, how FDA identifies it, and which documented characteristics distinguish one sterile lubricant from another.

What a catheter lubricant is

21 CFR 880.6375(a) defines a patient lubricant as “a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.” A urinary catheter is one such therapeutic or diagnostic device, so a lubricant used with it falls under this definition. Who uses it: nurses, clinic and hospital supply teams, home-care providers and procedure areas that stock lubricant alongside catheters. For the pack formats and handling of the jelly itself, see the guide to sterile lubricating jelly.

Lubricant versus a pre-lubricated catheter

The lubricant can be a separate product applied by the user, or it can already be part of the catheter. The second case is covered in pre-lubricated catheters; that page, not this one, explains how the built-in coating differs. The regulation above describes the standalone product, a lubricant sold on its own, which is the item this page is about. For the catheter formats a lubricant is paired with, see the urinary catheter types and selection guide.

How FDA classifies it

Item	Record	Source (checked 2026-11-01)
Device name	Lubricant, Patient	openFDA device classification, product code KMJ
Regulation number	21 CFR 880.6375	openFDA device classification; 21 CFR via Cornell LII
Device class	Class I (general controls)	21 CFR 880.6375(b); openFDA (device_class 1)
Medical specialty	General Hospital	openFDA device classification
Premarket notification (510(k))	Exempt, except when the device is a vaginal patient lubricant or an oral lubricant, subject to the limitations in 21 CFR 880.9	21 CFR 880.6375(b)
510(k) records under KMJ	49 records in the openFDA 510(k) database, including sterile lubricating jellies	openFDA 510(k) endpoint, product code KMJ

Because a lubricant for catheter use is generally exempt from premarket notification, the absence of a 510(k) number on a product does not by itself mean the product is unregulated. Many sterile lubricating jellies nevertheless have clearance records, so a 510(k) number, where a supplier gives one, can be looked up in FDA’s database.

Types and variants

The variant buyers meet most often is the sterile lubricant, sold as a sterile jelly. One FDA 510(k) summary (K092488, decision date 2009-12-18) shows what a sterile lubricating jelly of this kind looks like on paper.

Type	Typical use stated by the manufacturer	Key characteristics documented
Sterile lubricating jelly (example record: Dynarex, K092488)	Lubricates body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required	Clear, greaseless, water-soluble jelly; labeled non-staining, alcohol-free and fragrance-free; supplied as 3 g or 5 g foil packs and 2 oz or 4 oz tubes

The single-record example is an illustration of one manufacturer’s submission, not a survey of the market.

Questions to ask a supplier

This is not an official checklist. What an FDA record does show is the evidence one manufacturer put into its FDA summary (K092488), which is a reasonable list of documentation to expect a supplier to be able to describe:

• The sterility claim: the summary lists the product as sterile with a sterility test study.
• Composition statements: purified water, carbomer thickener and methylparaben, with the water-soluble, non-staining, alcohol-free and fragrance-free labeling.
• Physical tests: viscosity and pH.
• Preservative effectiveness testing.
• Biocompatibility testing under ISO 10993, with in-vitro cytotoxicity and implantation results in that record.
• Container material and pack format.

Sterile-field supplies are also discussed in the sterilization technology guide.

Safe use and handling basics

General principles only. Follow the manufacturer’s instructions for use printed on the pack, and follow your facility’s policy for single-use items. Infection-prevention practice around urinary catheters is described in the CAUTI prevention bundle. This page gives no step-by-step procedure for placing a catheter.

Common mistakes

• Treating the lubricant as an unregulated accessory. A patient lubricant under 21 CFR 880.6375 is a Class I device subject to general controls.
• Reading “no 510(k) number” as “not an FDA-regulated device”. The regulation makes most patient lubricants exempt from premarket notification, but they remain Class I devices under general controls.
• Treating a vaginal or oral lubricant as covered by the same exemption. The regulation carves those two out.

FAQ

Is catheter lubricant a medical device?

Yes. FDA identifies it as a patient lubricant, Class I, under 21 CFR 880.6375 (product code KMJ, checked 2026-11-01).

What does “sterile lubricant” mean here?

It means a lubricant supplied sterile, for use when a sterile field is required. The example 510(k) summary K092488 describes a sterile water-soluble jelly supported by a sterility test study.

Does every catheter lubricant need an FDA clearance number?

Not by the regulation’s own terms. Section 880.6375(b) exempts most patient lubricants from premarket notification, except vaginal and oral lubricants, subject to 21 CFR 880.9.

Sources

• 21 CFR 880.6375, Patient lubricant, Legal Information Institute (Cornell): https://www.law.cornell.edu/cfr/text/21/880.6375, checked 2026-11-01.
• openFDA device classification, product code KMJ: https://api.fda.gov/device/classification.json?search=product_code:KMJ, checked 2026-11-01.
• openFDA 510(k) records, product code KMJ: https://api.fda.gov/device/510k.json?search=product_code:KMJ, checked 2026-11-01.
• FDA 510(k) summary K092488, Dynarex Sterile Lubricating Jelly, 2009: https://www.accessdata.fda.gov/cdrh_docs/pdf9/K092488.pdf, checked 2026-11-01.